New · posted Oct 15
Praxis Precision Medicines · Biotechnology
Associate Director, Regulatory CMC
- Remote, US
- Remote
- Full-time
- Director
Open until filled
The role
The Associate Director, Regulatory CMC will be responsible for the planning, preparation, and execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for investigational and commercial products, including small molecule and antisense oligonucleotide (ASO) programs. This role will work closely with cross-functional partners and external vendors to support global regulatory submissions, health authority interactions, and lifecycle management activities.
The ideal candidate is a hands-on regulatory professional with strong CMC technical knowledge, a proactive ownership mindset, and a commitment to excellence, who thrives in a fast-paced biotech environment, takes full accountability for assigned programs, effectively partners with cross-functional teams, and consistently delivers high-quality, scientifically sound, and regulatory-compliant outcomes.
What you need
Qualifications and Key Success Factors
- Bachelor’s, Master’s, or Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or another relevant scientific discipline; 10+ years of progressively responsible experience in Regulatory CMC and/or technical CMC, or an equivalent combination of advanced education and experience.
- Demonstrated technical CMC expertise gained through hands-on experience as a subject matter expert in one or more CMC disciplines (e.g., formulation, analytical development, process development, manufacturing, chemistry, pharmaceutical development, or quality), with the ability to independently interpret complex scientific and manufacturing data and translate technical conclusions into sound regulatory strategies.
- Extensive hands-on experience preparing, reviewing, and/or managing CMC content for INDs, IMPDs, NDAs, BLAs, and post-approval submissions, with strong knowledge of FDA and global CMC regulatory requirements across development and commercial stages.
- Experience supporting small molecule drug products; experience with antisense oligonucleotides (ASOs) or other oligonucleotide-based therapies is strongly preferred.
- Demonstrated leadership of complex CMC regulatory activities, including health authority interactions, and the ability to influence cross-functional teams, build consensus among technical SMEs, and effectively work with external manufacturing, testing, and other development partners.
- Demonstrated ownership mindset with a proactive, can-do attitude and strong commitment to excellence; takes full accountability for assigned Regulatory CMC programs, anticipates and independently resolves complex issues, and consistently delivers high-quality, scientifically sound, and regulatory-compliant outcomes.
- Strong project management, organizational, written, and verbal communication skills, with the ability to manage multiple programs and priorities effectively in a fast-paced, cross-functional environment.
- Proficiency in leveraging AI tools and other digital technologies to enhance document preparation, review, data analysis, and day-to-day Regulatory CMC activities while maintaining scientific judgment, data integrity, confidentiality, and compliance with company policies.
Annualized Base Salary
$175,000—$200,000 USD
Compensation & Benefits
At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!
Company Overview
What you'll do
- Support development and execution of CMC regulatory strategies for investigational and commercial small molecule and ASO programs, under the direction of the Senior Director.
- Author, compile, and review CMC sections of regulatory submissions, including INDs, IMPDs, NDAs, BLAs, amendments, and post-approval supplements.
- Coordinate CMC content development with Quality, Analytical, Development, and Commercial Manufacturing teams.
- Support health authority interactions including briefing documents and information request responses.
- Maintain regulatory compliance for CMC activities supporting clinical and commercial supply.
- Assist with post-approval change management, comparability assessments, manufacturing changes, and technology transfers.
- Manage external consultants, CMOs, CROs, and regulatory vendors.
Pay and benefits
$175,000 – $200,000 a year
Employer provided99%
99% of medical, dental and vision premiums paid
Company-paid life insurance, AD&D and disability
6%
401(k) match up to 6%
Stock incentives and ESPP
Discretionary quarterly bonus
Generous PTO and paid holidays
Working conditions
Location: This position may be performed remotely but requires flexibility and a willingness to travel as needed.
Equal opportunity, accessibility and legal noticesPraxis Precision Medicines's statements, word for word
The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to [email protected].
Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 11% below the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in the US43 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $175,000 | — | $200,000 |
| All US (middle half) | $190,500 | $210,000 | $244,500 |
This role: Praxis Precision Medicines's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Praxis Precision Medicines's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- Regulatory submissions5
- Lab testing and methods3
- GMP and compliance2
- Documentation and SOPs2
- Investigations and CAPA2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Praxis Precision Medicines on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Regulatory2 67%
- Quality1 33%
By level
- Director2 67%
- Senior & Principal1 33%
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Associate Director, Regulatory CMC at Praxis Precision Medicines
Open until filled. $175K–$200K a year, employer provided.